Gefitinib for EGFR Sensitive Mutation Postoperative Stage Ib NSCLC Patients
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|ClinicalTrials.gov Identifier: NCT02526537|
Recruitment Status : Terminated (Similar study has revealed result of no benefit for participants)
First Posted : August 18, 2015
Last Update Posted : December 18, 2017
|Condition or disease|
Currently, whether adjuvant therapy should be applied to Stage Ib non-small cell lung cancer (NSCLC) patients who received radical resection remains controversial. CALGB9633 studies have shown that for patients with stage Ib NSCLC who received radical resection, postoperative adjuvant chemotherapy does not benefit for all patients, only patients with high risk (cancer diameter >4cm) can benefit. There is still no clear evidence that the postoperative adjuvant chemotherapy or other treatments can improve the survival rate for patients with stage Ib NSCLC.
The EGFR gene mutation rate is about 10% for European patients, and about 30-40% for patients of Asian origins. In a retrospective observation study of 1118 stage I to stage III NSCLC patients who received surgery, D'Angelo et al. found that the risk of death for patients with EGFR sensitive mutation is lower than those without mutation. The authors indicated that postoperative use of TKI for EGFR sensitive mutation patients might be the possible reason. Since the mutation rate of EGRF gene is higher in Asian patients, compared with patients of other origins, the investigators speculate that Asian patients might benefit for postoperative use of TKIs.
EGFR gene mutation detection is routinely prescribed nowadays for lung adenocarcinoma patients who received surgical resection. According to NCCN guideline, stage IB patients with high risk factors are recommended to receive adjuvant chemotherapy. For patients who can not tolerate or decline chemotherapy, non-specific treatment ( Chinese herbal medicine and nonspecific immunomodulators as adjuvant anti-cancer treatment for 2 years) is recommended, otherwise, TKIs（Gefitinib 250 mg daily for 2 years) is also an alternative choice if the cancer has EGFR sensitive mutation. Based on patient's own choice of postoperative adjuvant therapy , the patients were enrolled for observation of prognosis.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||The Postoperative Adjuvant Therapy of Gefitinib for High Risk Stage Ib NSCLC Patients With EGFR Sensitive Mutation, an Open, Paired, Non-interventional, Multi-center Clinical Study|
|Actual Study Start Date :||November 11, 2015|
|Actual Primary Completion Date :||June 7, 2016|
|Actual Study Completion Date :||June 7, 2016|
Stage IB NSCLC Patients with high risk factors and EGFR gene sensitive mutation who can not tolerate or decline chemotherapy and choose Gefitinib for postoperative therapy (Gefitinib 250 mg daily for 2 years).
Stage IB NSCLC Patients with high risk factors and EGFR gene sensitive mutation who can not tolerate or decline chemotherapy and choose Non-specific treatment.(Chinese herbal medicine and nonspecific immunomodulators as adjuvant anti-cancer treatment for 2 years).
- Relapse Free Survival in 2 years [ Time Frame: Treatment period: 2 years (24 months) ]
- Relapse Free Survival in 3 years [ Time Frame: Follow-up: 3 years ]
- 5 year Overall Survival [ Time Frame: Follow-up: 5 years ]
- Relapse Free Survival in 5 years [ Time Frame: Follow-up: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526537
|West China Hospital|
|ChengDu, Sichuan, China|
|Principal Investigator:||Lunxu Liu, Professor||West China Hospital|